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To study the effect of drug tadalafil in improving the urodynamic parameters in spinal cord injury patients.

â??TO STUDY THE EFFECT OF TADALAFIL IN IMPROVING URODYNAMIC PARAMETERS IN SPINAL CORD INJURY PATIENTS: A RANDOMISED CONTROLLED STUDYâ??

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/12/047913
Enrollment
66
Registered
2022-12-06
Start date
Unknown
Completion date
Unknown
Last updated
2023-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: S34- Injury of lumbar and sacral spinalcord and nerves at abdomen, lower back and pelvis level Health Condition 2: S14- Injury of nerves and spinal cord at neck level Health Condition 3: S24- Injury of nerves and spinal cord at thorax level

Interventions

Control Intervention1: calcium: To observe the effect of single dose of calcium 500mg by oral route in spinal cord injury patients after two hours of administration Control Intervention2: Calcium: To

Sponsors

Sawai Man Singh Medical College Jaipur
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients willingly giving an informed written consent to participate in study 2. Age group 18-65 year 3. Traumatic spinal cord injury with supra sacral lesion 4. Patient with compromise lower urinary tract functions

Exclusion criteria

Exclusion criteria: 1. Patient with diagnosed renal, liver, Cardiovascular, diabetes mellitus or any other medical illness where urodynamic study canâ??t be performed 2. Patient with history of allergy to tadalafil 3. Patient with urinary tract infection, diagnosed at the time of screening by urine analysis and urine culture 4. Any anatomical abnormalities where urodynamic study canâ??t be performed. 5. Patent with history of major pelvic surgery e.g. prostatectomy, augmentation cystoplasty or colectomy 6. Traumatic spinal cord injury patients with spinal shock. 7. Traumatic spinal cord injury patients LMN type bladder

Design outcomes

Primary

MeasureTime frame
1. Maximum detrusor filling pressure 2. Maximum bladder capacity 3. Bladder compliance 4. Change in maximum detrusor pressure at the time of leaking/voiding. 5. Observe the side effect/s of tadalafil in study group.Timepoint: BASELINE

Secondary

MeasureTime frame
To study the side effect profile of tadalafil in study group patients.Timepoint: at follow-up assessment

Countries

India

Contacts

Public ContactDR OMPRAKASH

SAWAI MANSINGH MEDICAL COLLEGE

OPURMI@GMAIL.COM7597202012

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026